Kornimate/medical-research-clean huggingface dataset:
retinoic acid homeostasis in neuropsychiatric diseases

Conditions: Major Depression; Alzheimer's Disease; Alcoholism; Schizophrenia

Summary: it is hypothesized, that local retinoic acid (ra) homeostasis is functionally involved in the pathophysiology of depression. in a cross-sectional (and partly longitudinal) analysis, serum ra status will be assessed in healthy controls and subjects with major depression, alzheimer's disease, alcoholism and in subjects with schizophrenia.

retinoids comprise of a group of small-molecule derivatives of vitamin a with retinoic acid (ra) representing the biologically most active endogenous form. ra has multiple functions central nervous system (cns). it is hypothesized, that local ra homeostasis is functionally involved in the pathophysiology of numerous neuropsychiatric diseases.

Eligibility criteria:
mdd-group inclusion criteria: * depressive episode in the context of unipolar major depression * at least 18 points or more on the bdi and hamd-17 exclusion criteria: * additional or comorbid axis-i or axis-ii disorder * current history of any neurological or other serious medical condition * any psychopharmacological treatment or substance use within the last two weeks or 5 half-lives (whichever is longer) of the respective substance * any oral or topical application of retinoid-containing preparations within the last 3 months ad-group inclusion criteria: * diagnosed ad exclusion criteria: * any other neurodegenerative disorder * any oral or topical application of retinoid-containing preparations within the last 3 months schizophrenia-group inclusion criteria: * subjects with schizophrenia * intended therapy with clozapine, olanzapine or aripiprazole * bmi: 18 - 29,9 kg/m2 exclusion criteria: * presence of diabetes or pathological glucose tolerance * presence of and chronic inflammatory disease * any psychopharmacological treatment of clozapine, olanzapine or aripiprazole within the last 3 months * any oral or topical application of retinoid-containing preparations within the last 3 months alcoholism-group inclusion criteria: * subjects with alcoholism who either still consume alcohol or are abstinent for at least 4 weeks exclusion criteria: * any oral or topical application of retinoid-containing preparations within the last 3 months * current history of any neurological or other serious medical condition despite liver diseases
study to evaluate the safety and tolerability of cc-92328 in participants with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this phase 1, first-in-human (fih), clinical study of cc-92328 will explore the safety, tolerability and preliminary biological and clinical activity of cc-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (r/r mm). the study will be conducted in two parts: monotherapy dose escalation (part a) and monotherapy dose expansion (part b).


Eligibility criteria:
inclusion criteria: participants must satisfy the following criteria to be enrolled in the study: 1. must understand and voluntarily sign an informed consent form (icf) prior to any study-related assessments/procedures being conducted. 2. willing and able to adhere to the study visit schedule and other protocol requirements. 3. participant is ≥ 18 years of age the time of signing the icf. 4. participant has a history of multiple myeloma (mm) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit. 5. have documented disease progression on or within 12 months from the last dose of their last myeloma therapy. 6. participant must have measurable disease. 7. participant has an eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 8. females of childbearing potential (fcbp) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 12 weeks after the last dose of cc-92328 9. males must practice true abstinence or agree to use a condom 10. fcbp and males must avoid conceiving from signing the icf, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of cc-92328. exclusion criteria: the presence of any of the following will exclude a participant from enrollment: 1. participant has symptomatic central nervous system involvement of mm. 2. participant had a prior autologous stem cell transplant ≤ 90 days prior to starting cc-92328. 3. participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting cc-92328. 4. participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting cc-92328, whichever is shorter. 5. participant is a pregnant or lactating female. 6. participant received live virus vaccines within at least 4 weeks prior to starting study drug. 7. participant has known active human immunodeficiency virus (hiv) infection. 8. participant has active hepatitis b or c (hbv/hcv) infection. 9. participant weight is ≤ 40 kg at screening.

Keywords: multiple myeloma first-in-human phase 1 relapsed or refractory cc-92328
a study to evaluate the safety and immunogenicity of mrna-1975 and mrna-1982 against lyme disease in participants 18 through 70 years of age

Conditions: Lyme Disease

Summary: the purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mrna-1975 and monovalent mrna-1982 against lyme disease in healthy adult participants.


Eligibility criteria:
inclusion criteria: * body mass index of 18 to 39 kilograms/square meter (inclusive) at the screening visit. * participants of nonchildbearing potential may be enrolled in the study. * for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy during the study intervention period, and agreement to continue adequate contraception or abstinence through 3 months following last study injection. exclusion criteria: * have chronic illness related to lyme disease or an active symptomatic lyme disease infection as suspected or diagnosed by a physician. * received treatment for lyme disease within the prior 3 months. * had previous vaccination against lyme disease or participated in the past in any vaccine study for lyme disease. * had a tick bite within 4 weeks prior to the study injection visit. * dermatologic conditions that could affect local solicited ar assessments (for example, tattoos; psoriasis patches affecting skin over the deltoid areas). * received systemic immunosuppressants for \>14 days in total within 180 days prior to the screening visit (for corticosteroids, ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. * history of myocarditis, pericarditis, or myopericarditis regardless of the timing of past medical history. * history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study injection. * has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the screening visit or plans to receive them during the study. note: other inclusion and exclusion criteria may apply.

Keywords: mrna-1975 mrna-1982 vaccine lyme disease vaccine messenger rna moderna
a study to evaluate safety and efficacy of ttp273 for 12 weeks in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this trial is a multi-center, randomized, double-blind, placebo-controlled parallel group, phase 2 study in subjects with type 2 diabetes mellitus on a stable dose of metformin to evaluate the safety and efficacy of ttp273 versus placebo glucose control and body weight following administration for 3 months.


Eligibility criteria:
inclusion criteria: * the subject has a 6 month diagnosis of type 2 diabetes mellitus prior to screening and meets the american diabetes association (ada) guidelines for type 2 diabetes mellitus. * on a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months prior to screening. * males. females of non-childbearing potential. * generally stable health without a history of major surgery or significant injuries within the last year and without an active infection. exclusion criteria: * diagnosis of type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring type 2 diabetes, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis. * participation in a clinical trial and receipt of an investigational product within 30 days. * participation in any formal weight loss program, or fluctuation of \> 5% in body weight, or having received medications approved for weight loss within 3 months prior to screening or contemplating such therapy during the trial. * previous surgical treatment of obesity. * have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice administered by someone other than the patient within 6 months prior to screening. * use of other diabetic agents except metformin within 3 months prior to screening. * history of pancreatitis. * blood donation of approximately 1 pint (500 ml) within 8 weeks prior to screening. * history of hemolytic anemia, chronic transfusion requirement or other condition rendering hba1c results unreliable. * history of men-2 or family history of medullary thyroid cancer. * history or presence of clinically significant disease (other than type 2 diabetes mellitus).
cvr registry evaluating flexitouch plus and conservative care vs conservative care only for treatment of lymphedema

Conditions: Lymphedema

Summary: subjects with lower extremity lymphedema will be prescribed, per standard of care, to either flexitouch plus with conservative care or conservative care only and be followed for 12 months.

conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (mld, performed either by a therapist or self-mld), exercises and skin care. subjects presenting to a vein clinic (center for vein restoration or cvr) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the flexitouch plus pneumatic compression device along with conservative care. subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).

Eligibility criteria:
inclusion criteria: 1. male or female 18 years of age or older. 2. diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (cvi)-related, unilateral, or bilateral). 3. clinical etiology anatomy pathophysiology (ceap) classification of c3 or higher. 4. willing to comply with prescribed care, protocol requirements, and study-related visits. 5. willing and able to provide consent to participate. exclusion criteria: 1. bmi \> 50. 2. significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction). 3. unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty). 4. heart failure (acute pulmonary edema, decompensated acute heart failure). 5. acute venous disease (\< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism. 6. significant peripheral artery disease (ankle-brachial index (abi) \< 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene). 7. active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease). 8. active cancer (cancer that is currently under treatment, but not yet in remission). 9. poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or munchausen syndrome. 10. any circumstance where increased lymphatic or venous return is undesirable. 11. currently pregnant or trying to become pregnant (for flexitouch plus and conservative care group). 12. current participation in any drug or other device clinical studies.

Keywords: lymphedema of leg chronic venous insufficiency primary lymphedema secondary lymphedema
the effect of under-nutrition on the human microbiota

Conditions: Pregnancy

Summary: the purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. in addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.


Eligibility criteria:
inclusion criteria: * greater than 12 weeks pregnant * between the ages of 18 and 40 years exclusion criteria: * less than 12 weeks pregnant

Keywords: gut microbiome vaginal microbiome oral microbiome human milk microbiome nutritional status
sex disparities in hypoxic vasodilation and impact of obesity

Conditions: Obesity; Vasodilation; Healthy

Summary: the purpose of this project is to examine key mechanisms contributing to sex-differences in hypoxic vasodilation and the impact of obesity, with particular emphasis on the sympathetic nervous system.

patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. this project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.

Eligibility criteria:
inclusion criteria: * bmi \>18 kg/m2 exclusion criteria: * pregnancy, breastfeeding * diagnosed sleep apnea or ahi \>10 events/hr * current smoking/nicotine use * increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy * nerve/neurologic disease * cardiovascular, hepatic, renal, respiratory disease * blood pressure ≥140/90 mmhg * diabetes, polycystic ovarian syndrome * communication barriers * prescription medications, sensitivity to lidocaine
hormone replacement trial against alzheimers' disease

Conditions: Postmenopausal Symptoms; Alzheimer Disease

Summary: the influence of postmenopausal hormone treatment on dementia is not clear. dysfunctions in the metabolism of amyloid in the disease of alzheimer result in an elevated presence of degradation products in cerebrospinal fluid. the degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy. postmenopausal women with and without history of breast cancer will be recruited for the trial.


Eligibility criteria:
inclusion criteria: * postmenopausal women * 40 - 65 years exclusion criteria: * longer than 10 years in menopause * thyroid dysfunction * hypertension * medical history of psychiatric comorbidity * alcohol and/or drug abuse * medical history of neurologic symptoms with cognitive symptoms
a prospective, randomized, three arms, open label study comparing the safety and efficacy of two formulations of pp110 to the active comparator preparation-h® cream in the treatment of bleeding hemorrhoids grades 2-3

Conditions: Bleeding Hemorrhoids

Summary: eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (pp110 gel), test-2 product (pp-110 medicated wipes) or control (preparation-h cream). test product usage: once daily, about 1-5 minutes prior to first bowel movement. control product usage: according to label, 3-4 times daily application to rectal region. at the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage. treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.


Eligibility criteria:
inclusion criteria: 1. age 18-70 2. bleeding hemorrhoids with / without pain 3. diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids 4. signed informed consent exclusion criteria: 1. known rectal sensitivity 2. rectal infection 3. grade iv hemorrhoids 4. use of anti-coagulants (except aspirin or plavix) within 30 days prior to enrollment 5. known inflammatory bowel disease 6. anal fissure 7. military personnel 8. female patients that are pregnant, or are not using a reliable method of birth control, or are nursing 9. patients who have been involved in another experimental trial within the past 30 days 10. patients presently diagnosed with cancer
bariatric and obstructive lung disease study ii

Conditions: Obesity; Asthma

Summary: the prevalence of obesity and asthma has significantly increased over the past two decades. the purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (ahr), one of the defining features of asthma. this research is being done to determine how weight or body size affects airway size and airway smooth muscle (asm) tone and function. the goal of the study will be to look at if and how, weight might affect lung functioning. the investigators hypothesize that low lung volumes in obesity lead to ahr by reducing airway caliber causing increased asm tone with impairment in deep inspiration (di) response similar to what is seen in asthma.


Eligibility criteria:
inclusion criteria: * age 18 years or older * bmi over 35 kg/m2 (bariatric) or bmi between 25 and 28 kg/m2 (control) * physician diagnosis of asthma and on active asthma medication (if asthmatic) exclusion criteria: * weight greater than 450 lbs * unstable cardiovascular disease * uncontrolled hypertension * renal failure on dialysis * cirrhosis * pregnant or lactating * bleeding disorders or coumadin use * recent hospitalization for asthma in the past 3 months * active smoking or more than 10 pack year smoking history
genotype influence on recovery after traumatic brain injury

Conditions: Brain Injury

Summary: genetic differences in response to brain injury may reasonably be expected to play a role in the initial consequences of traumatic brain injury and in the rate of recovery from such injury.

polymorphisms in the apolipoprotein e gene encode functional variants which differentially determine the rate at which neuronal repair can occur, and are associated with differences in expression of neurodegenerative processes, including traumatic brain injury. it is proposed that the accuracy of prediction of outcome after head injury will be significantly increased by inclusion of apoe genotype alone, or in combination with other variables such as severity of head injury, cognitive, electroencephalographic or neuroradiologic measures, or treatment strategies.

Eligibility criteria:
patients enrolled in the dvhip are subject to the following recruitment criteria: 1. mild, moderate or severe closed head injury, where the cut off between mild and moderate is defined by gcs\ 24 hrs or - foca cerebral contusion on ct/mri or loss of consciousness (loc) \> 12 hours. note: the definition of mild, moderate or severe head injury differs widely between centers and is absolutely not critical for the work proposed as we will use continuous measures of severity throughout. 2. within three months of first assessment. (in practice, patients may be recruited after 3 months. we will deal with this issue by covarying the time from injury to first assessment in our analyses). 3. rancho los amigos cognitive level of 5-7 at first assessment. 4. volunteer informed consent signed by patient of family. 5. military or veterans health care beneficiary. 6. age 17-55 exclusion criteria: 1. unwillingness to participate in rehabilitation program or cooperate with investigators. 2. history of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Keywords: traumatic brain injury
impact of the systematic use of the criteria stopp/start in short stay geriatric.

Conditions: Quality of Life; Drug Use

Summary: assess the impact of the systematic use of stopp/start tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.


Eligibility criteria:
inclusion criteria: * patient with more than 75 years old * hospitalized in geriatrics short-stay * patient with a written informed consent * patient with a social security scheme exclusion criteria: * severe dementia * not able to respond to sf-12 * disease at final stage * patient under legal protection (maintenance of justice, tutelage, legal guardianship)

Keywords: elderly people geriatric short-stay stopp/start criteria
sensory nerve coaptation in diep flap breast reconstruction

Conditions: Breast Cancer

Summary: restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. a prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (diep) flap breast reconstruction in maastricht university medical center between august 2016 and august 2018 and who returned between for a follow-up visit between the start of the study and august 2019. semmes-weinstein monofilaments were used for sensory testing of the breast.


Eligibility criteria:
inclusion criteria: * female patients 18 years or older * unilateral or bilateral diep flap breast reconstruction * returned for follow-up between august 2016 and august 2019 * informed consent exclusion criteria: * total flap loss complication * flaps that required a take-back * follow-up less than six months postoperatively * only one postoperative measurement at less than 12 months follow-up * mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Keywords: breast reconstruction diep flap sensory recovery breast sensation nerve coaptation